A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
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ClinicalTrials.gov Identifier: NCT04100616 |
Recruitment Status :
Recruiting
First Posted : September 24, 2019
Last Update Posted : September 5, 2021
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Condition or disease | Intervention/treatment |
---|---|
Overweight and Obesity Overweight or Obesity Obesity Obesity, Morbid Obesity, Abdominal Obesity; Familial Obesity; Endocrine Obesity, Visceral Obesity Hypoventilation Syndrome | Other: No intervention |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity |
Actual Study Start Date : | March 2, 2020 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | July 2023 |
Group/Cohort | Intervention/treatment |
---|---|
Obsese individuals
Patients with a BMI greater than or equal to 30
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Other: No intervention
There is no intervention for this study |
- Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 1 year ]Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among obesity types
- Validation of Sequencing Methods [ Time Frame: 1 year ]To validate the methods used to sequence samples
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Signed informed consent by patient
- Male or female patients age 18 and older.
- Diagnosis of obesity based on Body Mass Index (BMI) of 30 or greater.
Exclusion Criteria:
- Refusal by patient to sign informed consent form
- Treatment with antibiotics within two weeks prior to screening
- Treatment with probiotics within six weeks prior to screening
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100616
Contact: Sabine Hazan, MD | 18053390549 | drsabinehazan@progenabiome.com | |
Contact: Jordan Daniels, MS | 18053390549 | jordan@progenabiome.com |
United States, California | |
ProgenaBiome | Recruiting |
Ventura, California, United States, 93003 | |
Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com | |
Contact: Jordan Daniels, MS 805-339-0549 jordan@progenabiome.com | |
Principal Investigator: Sabine Hazan, MD |
Principal Investigator: | Sabine Hazan, MD | ProgenaBiome |
Responsible Party: | ProgenaBiome |
ClinicalTrials.gov Identifier: | NCT04100616 |
Other Study ID Numbers: |
PRG-005 |
First Posted: | September 24, 2019 Key Record Dates |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Only aggregated, deidentified data will be made available to other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypoventilation Obesity Hypoventilation Syndrome Obesity Obesity, Morbid Obesity, Abdominal Overweight Overnutrition Nutrition Disorders Body Weight Respiratory Insufficiency |
Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Apnea, Obstructive Sleep Apnea Syndromes Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |